CBIs Premier Forum on Electronic Submissions

Description

FDA now requires that all electronic submissions be in eCTD format. Although thereâ€™s no mandate that requires regulatory submissions be electronic, the widespread movement towards eCTD is tied directly to FDA preference.
Like the movement towards the electronic clinical trial, the motivation behind electronic submissions is the desire to improve and expedite drug development. Although the process is more efficient for sponsors and regulatory bodies alike, eSubmissions are complex and thereâ€™s often confusion surrounding the execution of an electronic submission.
Although a large portion of the industry is still novice when it comes to eSubmissions, several large and small companies already consider themselves eCTD experts. No matter your situation, CBIâ€™s Electronic Submissions Conference has been designed to be a valuable and thought-provoking event. Newcomers obtain proven strategies for eCTD implementation and all attendees receive valuable insight surrounding the complexities of content development, lifecycle management and transitioning to RPS.